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Home » FDA Calls for Label Update to Identify Fracture Risk in Stryker’s STAR Ankle
FDA Calls for Label Update to Identify Fracture Risk in Stryker’s STAR Ankle
There is a higher than expected risk of the polyethylene component of Stryker’s Scandinavial total ankle replacement (STAR) devices breaking as early as three to four years after implantation, the FDA said in an update on a post-approval study.